NCT05589753 Sleep Disordered Breathing With Opioid Use
| NCT ID | NCT05589753 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2019-05-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2019-05-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There is an increased risk for sleep disordered breathing (SDB), sleep-related hypoventilation and irregular breathing in individuals on chronic prescription opioid medications. Almost 30% of a veteran sleep clinic population had opioid-associated central sleep apnea (CSA). The proposal aims to identity whether oxygen and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in chronic opioid use via different mechanisms. We will study additional clinical parameters like quality of life, sleep and pain in patients with and without opioid use. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea with opioid use. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea.
Eligibility Criteria
Inclusion Criteria: * Veterans, age 18-89 years * Veterans with prescription opioids Exclusion Criteria: * Patients with BMI\>40kg/m2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control * Patients with history of unresolved/untreated cardiac disease, including recent myocardial infarction, recent bypass surgery, untreated atrial and ventricular tachy-bradycardias * Congestive heart failure with Cheyne-Stokes respiration (CSR) * Current unstable angina * Recent stroke * Untreated schizophrenia * Untreated hypothyroidism * Unresolved seizure disorder * Severe respiratory, neurological, liver and renal diseases * Unstable psychiatric disorders/untreated PTSD * Traumatic brain injury * Pregnant women * Significant sleep disorder such as narcolepsy, parasomnias disorder * Failure to give informed consent * Patients on tramadol and suboxone/buprenorphine
Contact & Investigator
Susmita Chowdhuri, MD MS
PRINCIPAL INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI
Frequently Asked Questions
Who can join the NCT05589753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05589753 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05589753 currently recruiting?
Yes, NCT05589753 is actively recruiting participants. Contact the research team at ruchi.rastogi@va.gov for enrollment information.
Where is the NCT05589753 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT05589753 clinical trial?
NCT05589753 is sponsored by VA Office of Research and Development. The principal investigator is Susmita Chowdhuri, MD MS at John D. Dingell VA Medical Center, Detroit, MI. The trial plans to enroll 150 participants.